WO2016146640A1

WO2016146640A1 - Infusion-, dilation- and aspiration-catheter (idac)

Info

Publication number: WO2016146640A1
Application number: PCT/EP2016/055602
Authority: WO
Inventors: Gerhard-Friedrich Horak
Original assignee: Gerhard-Friedrich Horak
Priority date: 2015-03-17
Filing date: 2016-03-15
Publication date: 2016-09-22
Also published as: JP2018508334A; DE202015002060U1; CN107548297A; US20180110533A1; EP3271001A1

Abstract

A system (1) consists of an aspiration catheter (2), which is guided by means of a guide wire (3) to a thrombotic point in a blood vessel. A collapsed infusion balloon (4) is located inside the aspiration catheter (2), which has an interior/inner volume (40) delimited by a wall (41), and a delivery catheter (42). The delivery catheter (42) is intended for delivering saline solution (salt solution) for rinsing or a thrombus-dissolving drug into the interior (40). The balloon comprises a plurality of openings which have a diameter between 10 µm and 100 µm in order to enable an atraumatic application of fluid.

Description

Infusion, Dilatation and Aspiration Catheter (IDAC)

(Catheter for removal of thrombi and application of drugs)

STATE OF THE ART

It is known to remove thrombi or thrombotic material from blood vessels by means of so-called aspiration or suction catheters. For this purpose, the aspiration catheter is introduced and guided to the thrombotic site. Subsequently thrombotic material can be removed from the blood vessel via the aspiration catheter. The aspiration catheter is advanced for this purpose until its distal end reaches the area from which thrombotic material is to be aspirated. The material is now aspirated through the lumen of the suction catheter, e.g. using a Luer Lock syringe.

A disadvantage of this method and the catheters designed for this purpose is that the thrombotic material agglomerated in the blood vessel may under certain circumstances be difficult to detach from the vessel wall. In addition, the detached agglomerates can be relatively bulky, so that a targeted suction through the aspiration catheter can be difficult. In addition, there is a risk that dissolved thrombotic material removed from the site of the intervention and attached elsewhere or in the vascular system and possibly there clogged another. There is thus a high risk of further thrombotic blockages (e.g., the cerebral artery).

On the other hand, infusion catheters are known, by means of which saline solutions (saline solutions) for rinsing or medicaments (for example thrombolytic drugs) are supplied in order to remove dissolved thrombotic material or to dissolve thrombotic material (debris / plaque) from the vessel wall.

A disadvantage of these techniques is that, on the one hand, the effect of the medicament administered by a conventional infusion catheter, eg a microcatheter, which essentially consists of a lumen with a distal opening, is low due to dilution effects. For that reason, on the other hand, a large amount must be be supplied to the drug. However, the uncontrolled drug or detached thrombi may enter other areas of the bloodstream under these circumstances, which can lead to significant side effects such as strokes.

OBJECT OF THE INVENTION

Based on this, the object of the invention is to provide a catheter which solves the problems mentioned and ensures a rapid and uncomplicated removal of thrombotic material.

TECHNICAL SOLUTION

This object is achieved by a system according to one of claims 1 or 13 and by an infusion balloon according to claim 10. Further preferred embodiments result from the features of the dependent claims.

The system for removing thrombotic material from a blood vessel comprises an aspiration catheter and an infusion element, the infusion element having a delivery catheter for delivering a fluid and an expandable balloon connected to the delivery catheter, the balloon having openings and / or at least one (semi ) permeable wall portion for passage of the fluid, wherein the infusion member is movably receivable in a first lumen of the aspiration catheter and movable therethrough.

The problem with conventional systems is that when a thrombolytic drug is delivered to a thrombotic vessel, incompletely dissolved thrombotic material and / or debris / plaque may be transported on, and may be elsewhere, e.g. can cause a stroke in the brain, hemorrhagic insult, or other complications.

The solution according to the invention allows the balloon, initially within the first

Lumens of the aspiration catheter is arranged, together with the

Introduce aspiration catheter into the blood vessel. Subsequently, the balloon (eg by means of a guide wire for the infusion element) from the first lumen to the height of the thrombus-occupied and narrowed site in the blood vessel. Thus, on the one hand thrombi are fixed to the vessel wall, on the other hand solved by the applied liquid, but can not migrate uncontrollably.

The balloon is then dilated via the delivery catheter by adjusting the pressure and the amount of fluid, e.g. liquid drug (thrombolytic drug) is increased.

Upon reaching a certain pressure, the balloon has reached a size where the outside of its wall abuts the wall of the blood vessel and the thrombi are fixed in place.

From a certain internal pressure of the drug the wall or the openings of the balloon for the drug becomes permeable.

When the outer skin / outside of the wall of the balloon abuts against the wall of the blood vessel, the balloon has an outside diameter (relative to a projection of the balloon normal to the vessel wall) that is larger than the inside diameter of the first lumen of the aspiration catheter. The balloon exerts a significant pressure on the vessel wall. Thus, on the one hand dissolved thrombi are at least partially fixed by the balloon and can not be removed, on the other hand is due to the close contact and variable contact pressure of 2 to 10 bar, in particular at least 4 bar, in particular at least 6 bar between the outer wall of the balloon and vessel wall achieved extremely effective application of the drug.

The openings and / or the (semi) permeable wall area are in particular designed in such a way that an atraumatic application of the fluid occurs at a predetermined fluid pressure.

The contact pressure to be achieved in turn is achieved by a high internal pressure of the liquid within the balloon of 2 to 10 bar, in particular of at least 4 bar, in particular of at least 6 bar. In order to achieve sufficiently high pressures despite the openings in the balloon, the openings must be relatively small, in particular between 10 μηι and 100 μηι, preferably between 10 μηι and 60 μηι, more preferably between 20 μηι and 50 μηι.

On the other hand, an effective application of the drug is achieved by a high number of small openings, so that a kind of liquid film or a slow wetting of the outside of the balloon occurs while an internal pressure between 2 to 10 bar is maintained. The balloon has an areal density of openings (i.e., openings per unit area) of said size of at least

25 openings per cm 2, in particular at least 50 openings per cm 2, in particular at least 100 openings per cm 2, in particular at least 500 openings per cm 2, in particular at least 1000 openings per cm, in each case averaged over the entire outer surface of the balloon ( in the dilated state). In particular, openings are provided both in the proximal end near portion and in the distal end adjacent portion. There are substances which in a high concentration also dissolve old and / or large thrombi. However, administered systemically in high concentrations, these drugs could cause bleeding and other complications.

The balloon may have at least 50 openings, in particular at least 100 openings, in particular at least 500 openings, in particular at least 1000 openings.

The size of the balloon in terms of length, diameter, volume or surface - each in a dilated state - may vary. In particular, the length 1 may be between 10 mm and 20 mm for balloons for the coronary region, between 10 mm and 300 mm for balloons for the peripheral region. The diameter may be between 1 mm and 4 mm for balloons for the coronary area, and between 1 mm and 8 mm for the peripheral area. In the non-dilated state, for example, the diameter of the balloon may be about 1 mm.

The infusion element is arranged in particular axially displaceable in the first lumen of the aspiration catheter. The infusion element itself can have a guide element, for example a guide wire, in order to be able to displace the infusion element within and out of the first lumen. The balloon is designed as a microballoon, which can be taken up in the first lumen of the aspiration catheter in the non-dilated state and passed through the first lumen.

The balloon is only starting from a certain internal pressure, e.g. 2 bar, permeable to the drug. With the help of a pressure spray, higher internal pressures of up to 10 bar can be achieved. That Only after a certain pressure / volume drug is administered, in particular only when the outer skin already rests against the wall of the blood vessel.

In particular, the aspiration catheter has a proximal end and a distal end and a longitudinal axis, and the distal end is preferably bevelled.

The system may include a guide member fixed to the aspiration catheter.

The aspiration catheter preferably has a second lumen in which the guide element (e.g., guidewire) is at least partially embedded.

The object is achieved by a balloon for a system as described, wherein the balloon has a plurality of openings having a diameter between 10 μιη and 100 μιη, in particular between 10 μιη and 60 μιη, in particular between 20 μιη and 50 μιη.

The balloon may have a plurality of apertures having an average areal density (i.e., apertures per unit area) of at least 25 apertures per cm 2, more preferably at least 50 apertures per cm 2, more preferably at least 100

Openings per cm 2, in particular at least 500 O "openings per cm 2, in particular at least 1000 openings per cm, have.

The balloon may have at least 50 openings, in particular at least 100 openings, in particular at least 1500 openings, in particular at least 1000 openings. The balloon may also be constructed as a semipermeable balloon.

Preferably, the arrangement of the openings can also be determined by their average distance. The average distance is in the invention between the distance between adjacent openings 43 is on average less than 2 mm, preferably less than 1.4 mm, in particular less than 0.7 mm, more preferably less than 0.45 mm, in particular less than 0.3 mm. These values result from the density of the apertures over a unit area, as described above. In the context of the application, however, arrangements of openings should also be protected in which the surface density, as stated above, is realized only over a certain area of the surface of the balloon. However, in these surface areas, the surface density of the openings (local) should be as indicated above. This means that the mean distance between adjacent openings, if the openings have a nearest neighbor, in these areas in the above areas.

In conjunction with the absolute number of openings can be calculated, which surface portion of the balloon must have openings in the invention.

The design of the balloon and its openings effective application of the effective solution is achieved. The drug acts directly on the site to be treated. After delivery to the thrombus, the drug spreads throughout the bloodstream and has a systemic effect.

In particular, the balloon is made of nylon, polyethylene terephthalate (PET), polyamide, polyethylene, and / or polyether block amides (PEBA). It may have openings as described above or at least partially made of (semi-) permeable material, which diffuses the liquid at a corresponding internal pressure or penetrate the membrane.

The apertures are preferably made by laser treatment (e.g., laser cutting, punctiform apertures). In individual cases, however, it is also possible to use e.g. a mechanical formation of the openings take place.

After the thrombi have been released by selective selective infusion of medicament and dilatation, the internal pressure and thus the volume of the balloon are lowered to such an extent that it can be withdrawn through the first lumen of the aspiration catheter. For this purpose, for example, a negative pressure is applied, which causes a collapse or folding of the balloon. As the balloon is withdrawn through the first lumen, it substantially closes with the first lumen of the suction catheter. The result is a negative pressure (negative pressure) or a suction effect (Windkessel effect), the further already dissolved thrombotic material already in this early phase draws into the aspiration catheter and thus removed from the blood vessel.

When the balloon is completely withdrawn from the first lumen, a device for generating a negative pressure or suction is connected at the proximal end of the aspiration catheter, e.g. a suction syringe (e.g., Luer Lock syringe) to remove as much of the remainder of the dissolved thrombotic material as possible.

In addition, the permeability is reversible or follows a hysteresis. In reversible training, the openings close below the first certain pressure again, so that the volume can be further reduced to a desired value.

At a hysteresis, the transmittance disappears upon reaching a second predetermined pressure, which does not have to correspond to the first predetermined pressure.

But it may also be that the permeability of the balloon does not change or only quantitatively when reducing the pressure. By adjusting / reducing the fluid pressure inside to a third predetermined value, it is possible to create a dynamic equilibrium, i.e. by appropriate delivery of medicament to the balloon. The balloon loses just as much drug as it is being delivered, thus maintaining its volume.

In the context of the invention, a method is claimed, which was carried out in particular with the system according to the invention, as described in this application.

The method comprises the following steps: a) providing a system as described above; b) introducing the system into a blood vessel and bringing the distal end of the aspiration catheter to the site to be treated (with the infusion element disposed within the first lumen of the aspiration catheter); c) moving the balloon out of the first lumen of the aspiration catheter to the height of the site to be treated; d) Dilatation of the balloon by introducing a liquid and / or increasing the fluid pressure in the interior of the balloon, wherein from a certain internal pressure, the fluid passes through the balloon-formed openings out through the balloon wall (ie atraumatic application of the liquid at the site to be treated ); e) deflation and retraction of the balloon through the first lumen; and f) aspiration, ie, aspiration of thrombotic material from the blood vessel through the first lumen of the aspiration catheter.

In step d), the balloon is preferably widened so that it bears against the inner wall of the blood vessel or presses against it with a predetermined pressure.

Further method steps have already been described and can be combined in combination with the method steps a) to f) to describe particular embodiments of the method.

Another system for removing thrombotic material from a blood vessel according to the present invention comprises an aspiration catheter having a first lumen for aspirating thrombotic material from a blood vessel and a guide member for introducing the aspiration catheter into the blood vessel, wherein the guide member (formed as aspiration catheter and / or or microcatheter) has a proximal end and a distal end and a third lumen through which fluids are transportable from the proximal end of the guide member to the distal end of the guide member.

The guide element preferably has at least one infusion opening, which is formed in the region of the distal end of the guide element.

In particular, the aspiration catheter has a longitudinal axis and the distal end may be chamfered.

The guide element is fixed in particular on the aspiration catheter. The distal end of the guide member may protrude beyond the edge of the opening of the second lumen of the aspiration catheter.

The cross section of the first lumen is in particular larger than the cross section of the second lumen.

The guide element can be designed as a microcatheter and thus act as an infusion element.

BRIEF DESCRIPTION OF THE FIGURES

Further features and advantages of the present invention will become apparent from the description of preferred embodiments in conjunction with the following figures. Show it:

FIG. 1 A representation of an embodiment of the fiction, contemporary

Systems in a first phase of the inventive method;

Figure 2 is a representation of the embodiment of Figure 1 in a second

Phase of the inventive method;

Figure 3 is a representation of the embodiment of Figure 1 in a third phase of the inventive method;

Figure 4 is a representation of the embodiment of Figure 1 in a fourth phase of the inventive method;

Figure 5 is a representation of the embodiment of Figure 1 in a fifth

Phase of the inventive method;

Figure 6 is an illustration of an embodiment of the Invention according

Infusion balloon;

FIG. 7 A representation of a detail of the infusion balloon according to the invention from FIG. 6;

FIG. 8 shows a second embodiment of the infusion,

Dilatation and aspiration catheter; FIG. 9 A cross section AA of the aspiration catheter according to FIG. 8.

DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1 shows a system 1 according to the present invention during a surgical procedure in a blood vessel B. The blood vessel B may in particular be a coronary vessel on whose wall a thrombus B (plaque) has deposited and forms a constriction to be treated.

The system 1 includes an aspiration catheter 2 having a first lumen 20, a distal end 21 (with a distal opening 210) and a proximal end with a proximal opening (not shown). A central axis 22 extends longitudinally between the proximal end and the distal end 21.

The system 1 also includes a guidewire 3, which also has a proximal end (not shown) and a distal end 30. The guide wire 3 is arranged in a second lumen of the aspiration catheter 2. The guide wire 3 is immovably connected to the aspiration catheter 2 so that the guide wire 3 is not longitudinally displaceable with respect to the aspiration catheter 2. It protrudes beyond the distal opening of the second lumen. The surface defined by the edge of the opening 210 of the aspiration catheter 2 is inclined with respect to the axis 22 at an angle of approximately 45 °.

Within the aspiration catheter 2 is an infusion element, with infusion balloon 4 collapsed at this time, having an interior / interior volume 40 delimited by a wall 41 and a delivery catheter 42. The balloon 4 is folded to have a low profile has, ie the cross-section is such that the balloon can be placed in the aspiration lumen and moved therethrough.

Delivery catheter 42 is designed to deliver saline solution (saline) for rinsing or thrombolytic drug into interior space 40. Optionally (not shown), the balloon 4 has an actuating element, for example a separate one

Guide wire, so that it can be moved relative to the aspiration catheter 2 in the direction of the longitudinal axis 22 back and forth. In the first phase of the procedure shown in FIG. 1, the catheter 2 is introduced into the blood vessel by actuation of the guide wire 3 together with the (still folded) balloon 4, which is arranged in the first lumen 20 of the aspiration catheter 2 (namely in the aspiration lumen) until he reaches his destination position. The determination position is reached when the opening 210 is located a certain distance in front of the thrombus T. The distal end 21 of the catheter 2 in this position reaches the constriction (caused by the thrombus) to be treated.

In the second step shown in FIG. 2, the balloon 4 is pushed out of the first lumen 21 until it is approximately at the level of the thrombotic site to be treated. There it is unfolded and / or dilated by introducing a drug via the delivery catheter 42. For this purpose, a pressure syringe is preferably used, which can generate correspondingly high and defined internal pressures in the interior 40 of the balloon 4. The drug M is, when the internal pressure of the drug has reached a certain limit, applied via a plurality of micro-openings 43 from the interior 40 of the balloon 4 in the blood vessel B. Due to the small diameter of the openings of 10 μιη to 100 μιη the drug M penetrates only slowly from the balloon interior 40 from. The drug wets more or less the outer side of the balloon wall 41. At the same time it is ensured by the formation of the openings 43 with the diameters mentioned that in the interior 40 a relatively high pressure of 2 bar to 10 bar is maintained. As a result, the balloon wall 41 presses against the region of the wall of the blood vessel B at which thrombotic material is deposited at high pressure.

Due to the nature of the application - high pressure of the balloon 4 to the vessel wall with simultaneous slow escape of the drug M from the plurality of small openings 43 - an atraumatic, at the same time extremely effective and intensive application of the drug M is guaranteed exactly at the point to be treated T. The increase in the effect of the drug may be compared to intravenous administration in the 4-digit range. The drug M unfolds (practically only) at the site of the application its effect, for example by the thrombus T is dissolved. FIG. 3 shows the next phase of using the system 1, in which the volume of the internal space 40 is reduced by reducing the pressure of the medicament M in the interior 40 of the balloon 4. The balloon body 40 collapses and returns to approximately its original dimensions. The openings 43 may, but need not reversibly close (or along a hysteresis loop), so that from a certain internal pressure no drug is applied.

Meantime, the administered medicament M unfolds its effect, which is indicated by the dissolution or comminution of thrombotic material D. Thrombotic material D _h , which bears against the outside of the wall 41, can adhere to this. Further thrombotic material D may be present dissolved in the blood vessel B.

Subsequently, as shown in Figure 4, the balloon 4 is pulled through the opening 210 and the first lumen 21 to the proximal end of the aspiration catheter 4.

The balloon is folded so that it has a low profile, i. the cross-section is such that the balloon fits into the aspiration lumen and can be withdrawn therethrough.

By pulling out, the balloons 4 can produce a suction effect, indicated by the arrows of the debris particles D following the suction (wind boiler effect), and remove thrombotic material D from the blood vessel B through the first lumen 20.

In the next step according to FIG. 5, the thrombotic material D is sucked off via the first lumen 20. For this purpose, a suction device is attached to the proximal end of the aspiration catheter 4 (not shown). In this way, the remaining in the blood vessel B thrombotic material D is largely removed.

Thereafter, the application is completed and the system 1 can be removed from the blood vessel B.

FIG. 6 schematically shows the structure of a microballoon according to the invention.

Infusion balloon 4 in a dilated state. In the dilated state is the

Diameter h between 1 mm and 4 mm. In addition, the balloon volume 40 has a Length 1 from 10 mm to 20 mm. In particular, the plurality of openings 43 (indicated by the multiplicity of points, only one of which is marked by the reference numeral 43) are formed both in the proximal and in the distal part region of the balloon body 4. The introduced into the balloon 4 liquid should in particular also act in the distal region of the balloon.

Upon delivery and increase of the internal pressure of the drug M or saline solution, the internal volume 40 of the balloon 4 increases until, during treatment, the outside of the wall or skin 41 of the balloon 4 abuts the wall of the blood vessel and encloses thrombotic material there or pressed against the wall.

The balloon has the following geometry: In the inflated state, the balloon is substantially cylindrical or tubular with a central axis Z and a radius of h / 2. At each end, the balloon 4 has an annular shoulder 44a and 44b, respectively. The annular shoulder has a radius which corresponds approximately to that of the outer shell of the cylindrical body. At the level of the shoulder 44a and 44b, respectively, a radiopaque marker 45a and 45b is arranged to allow localization of the balloon 4, in particular to ensure that the balloon is located in the area of the thrombus prior to inflation.

The balloon body 40 has, distributed over the entire length 1 or at least over an effective range l _e , which is at least 75% of the length 1, openings 43.

These have, as can be seen from the detail view of FIG. 7, a diameter d which lies between 10 μm and 100 μm. As the internal pressure increases, the diameter d increases so that the supplied medicament or the solution can slowly escape atraumatically above a certain limiting pressure.

The number of openings is on average - based on the entire surface of the dilated balloon body 40 at least 25 openings per cm, preferably over

50 openings per cm 2, preferably over 200 openings per cm 2, preferably over

500 openings per cm 2, preferably over 1000 openings per cm 2. Preferably, the arrangement of the openings can also be determined by their average distance aj, a _j , .... The average distance is in the invention between the distance ai, aj, .. between the openings 43 is on average less than 2 mm, preferably less than 1.4 mm, in particular less than 0.7 mm, more preferably less than 0, 45 mm.

The total number of apertures formed in the balloon body 40 is over 50 apertures and may even be 100 apertures or more. These can be distributed more or less homogeneously over the wall 41.

Due to the small diameter of the openings 43 can - despite the high number of openings - the internal pressure can be significantly increased without too much drug is applied in a short time and precludes the construction of a high internal pressure. The balloon can cause a greater expansion of the vessels and a greater pressure against the vessel wall by the increased internal pressure.

As a material for the preparation of the wall or skin 41 of the balloon body 40 / the balloon 4 is for example nylon.

In a non-dilated state, the diameter h is so small that the balloon can be arranged in the first lumen 21 of the delivery catheter 2 and moved through the first lumen 20 of the aspiration catheter 2. The size of the aspiration catheter or the cross-sectional area of the first lumen 20 must therefore be adapted to the cross-sectional area of the non-dilated balloon 4, i. in particular, the balloon body cross section must be smaller or lie in the size range of the cross section of the first lumen 21.

The drug should be applied as atraumatic as possible. In order to increase the internal pressure significantly, for example, a pressure syringe is usually used instead of a normal (manual) syringe. With the pressure spray not only larger pressures, but also defined pressures can be generated. As a result, the balloon dilates much more and it is greater pressure, for example, up to 10 bar, exerted on the arterial wall. As a result, the liquid is applied very targeted and plaques and Tromben be better resolved on the vessel wall. The balloon pressing against the wall holds loose plaque parts so that they can not be transported to other areas of the body. This type of application achieves multiple receptor binding compared to intravenous administration. The application can also be targeted locally. The application takes place, for example, for one minute. The arterial volume in the heart area is 1-2 ml. It is rinsed with 10 ml of saline solution or medication.

An alternative embodiment of the inventive system 1 is shown in FIG.

In contrast to the first embodiment, the system 1 does not have a balloon 4 in this case. Instead, a liquid is applied via the guide element 3 of the aspiration catheter 2.

As shown in FIG. 9, the aspiration catheter 2 has a first lumen 20 (suction lumen), and a second lumen 23 for guiding the guide element 3.

In the guide member 3 extends between the proximal end (not shown) and the distal end portion 30, which projects beyond the opening 230 of the second lumen 23, a third lumen through which the drug M is administered in the second phase of the application. For this purpose, the distal end region 30 of the guide element 3, for example, openings 33 through which the liquid can get into the blood vessel B. The guide element 3 is in this case designed as a microcatheter or infusion catheter with the third lumen for supplying the medicament to the openings 33 arranged in the distal region 30.

FIG. 9 shows a section A-A from FIG. 8 for clarity. The first lumen 20 is used in this embodiment only for sucking the dissolved thrombotic material D (suction lumens 20). The second lumen 23 serves to receive the guide element 3 in a stationary manner. The latter has a third lumen for administering a liquid M.

Application and the description of the first embodiment are otherwise applicable to the second embodiment.

Claims

A system (1) for removing thrombotic material from a blood vessel, comprising an aspiration catheter (2) and an infusion element, the infusion element having a delivery catheter (42) for delivering a fluid and an expandable balloon (4) connected to the delivery catheter (42), wherein the balloon (4) has openings (43) and / or at least one (semi) permeable wall area for the passage of the fluid, characterized in that the infusion element is movable in a first lumen (20) of the aspiration catheter (2 ) is receivable and movable therethrough,

2. System (1) according to claim 1, characterized in that the openings (43) and / or the (semi) permeable wall area are formed such that from a predetermined fluid pressure an atraumatic application of the fluid takes place.

3. System (1) according to any one of the preceding claims, characterized in that the infusion element is arranged axially displaceably in the first lumen (20) of the aspiration catheter (2).

4. System (1) according to any one of the preceding claims, characterized in that the openings (43) have a diameter between 10 μιη and 100 μιη, in particular between 10 μιη and 60 μιη, in particular between 20 μιη and 50 μιη.

5. System (1) according to one of the preceding claims, characterized in that the balloon (4) has a plurality of openings (43) with an average density per unit area of at least 25 openings per cm, in particular at least 50 openings per cm, in particular at least 100 Openings per cm 2, in particular at least 500 openings per cm 2, in particular at least 1000 openings per cm.

6. System (1) according to any one of the preceding claims, characterized in that the balloon (4) has at least 50 openings, in particular at least 100 openings, in particular at least 500 openings, in particular at least 1000 openings.

A system (1) according to any one of the preceding claims, characterized in that the aspiration catheter (2) has a proximal end and a distal end (21) and a longitudinal axis (22), and the distal end (21) is chamfered.

8. System (1) according to any one of the preceding claims, characterized in that the system comprises a guide element (3) which is fixed to the aspiration catheter (2).

9. System (1) according to any one of the preceding claims, characterized in that the aspiration catheter (2) has a second lumen (23) in which the guide element (3) is embedded at least in sections.

10. balloon (4) for a system according to one of the preceding claims, characterized in that the balloon (4) has a plurality of openings (43) having a diameter between 10 μιη and 100 μιη, in particular between 10 μιη and 60 μιη , in particular between 20 μιη and 50 μιη have.

A balloon (4) according to claim 10, characterized in that the balloon (4) has a multiplicity of openings with an average areal density of at least 25 openings per cm, in particular at least 50

Openings per cm 2, in particular at least 100 openings per cm 2, in particular at least 500 openings per cm, in particular at least 1000

Openings per cm 2, has.

12. balloon (4) according to claim 10 or 11, characterized in that the balloon (4) has at least 50 openings, in particular at least 100 openings, in particular at least 500 openings, in particular at least 1000 openings.

A system (1) for removing thrombotic material (T) from a blood vessel (B), comprising an aspiration catheter (2) having a first lumen (20) for aspirating thrombotic material (D) from a blood vessel (B) and a guide member (3) for introducing the aspiration catheter (2) into the blood vessel (B), the guide member (3) having a proximal end and a distal end (30) and a third lumen through which fluids from the proximal end of the Guide element (3) to the distal end (30) of the guide element (3) are transportable.